Health Care Checkup
January 7, 2022
THE BIG PICTURE
The Senate returned to Washington this week from the holiday recess, but no real progress has been made on the advancement of their $1.75 trillion social investment bill, the Build Back Better Act (BBB). On Tuesday, Senate Democratic Whip Dick Durbin (IL) said that negotiations on BBB will pause until the Senate addresses voting rights legislation, which could last through the end of the month. Additionally, Senator Joe Manchin (D-WV) told reporters that negotiations on the bill have come to a halt. Talks are expected to resume, but the timeline is currently unknown.
 
On Thursday, CMS issued a proposed rule for the Medicare Advantage and Medicare Part D programs. The proposed rule would require Medicare Part D plans to pass on savings to consumers at the pharmacy counter, revise Medicare Advantage marketing and communications requirements by strengthening oversight of third-party marketing organizations and seeks greater transparency in Medical Loss Ratio (MLR) reporting by reinstating reporting requirements that were in place from 2014-2017. The press release can be found here and the fact sheet can be accessed here
 
On Tuesday, the CDC announced that it has shortened the booster interval from 6 months to 5 months for people that received two doses of Pfizer’s COVID-19 vaccine. The booster interval recommendation has not changed for the Johnson & Johnson vaccine (2 months) or for the Moderna vaccine (6 months). The CDC also recommended that “moderately or severely” immunocompromised 5–11-year-olds receive an additional dose of the Pfizer vaccine 28 days after their second shot.
 
On January 1, surprise medical billing measures went into effect to help protect consumers from high, unexpected medical bills. As a reminder, in late September 2021, the Biden Administration released an interim final rule to further implement the No Surprises Act on surprise medical billing. The new regulations create a process by which providers, health plans, and issuers can settle payment rate disputes. Specifically, under the new regulations, unresolved disputes between providers and insurers are solved by third-party arbiters who will determine a payment rate based on the median in-network rate. Additionally, patients can no longer be charged an out-of-network rate for emergency care received at an out-of-network facility, nor for services received by an out-of-network provider at an in-network facility.

On Wednesday, a group of House Democrats, led by Representative Pramila Jayapal (D-WA), sent a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure, requesting that the Direct Contracting Model be permanently ended. The lawmakers also requested that the agencies coordinate the transition of traditional Medicare beneficiaries currently enrolled in these programs back into the traditional Medicare model by July 1 of this year. The full letter can be viewed here.
 
CMS announced on December 28 that it would move ahead with enforcement of its vaccine mandate, which requires that workers at health care facilities participating in Medicare and/or Medicaid be fully vaccinated against COVID-19. Workers at these facilities must receive their first shot by January 27 and their second shot by February 28. The mandate will not yet be enforced in the 25 states that have pending lawsuits over the rule. The U.S. Supreme Court held a special hearing on Friday, January 7 to consider challenges to the mandate. The Supreme Court also heard arguments over the Occupational Safety and Health Administration’s (OSHA) testing and vaccine mandate, which requires that companies with 100 or more employees require their personnel to either get fully vaccinated against COVID-19 or submit to weekly testing.
 
On Friday, House Speaker Nancy Pelosi (D-CA) invited President Biden to deliver the State of the Union address on Tuesday, March 1, 2022. The text of the letter can be found here
What to Expect Next Week: Next week, the Senate HELP Committee will hold a hearing on Tuesday titled, “Addressing New Variants: A Federal Perspective on the COVID-19 Response.” The HELP Committee will also hold a vote on Wednesday, which will determine if Robert Califf’s FDA Commissioner nomination will be sent to the Senate floor for a final confirmation vote. Talks on Build Back Better will likely remain on pause until Senate Democrats finalize their voting rights legislation, which remains their top priority for the time being. 
DEEP DIVE
Negotiation on the Build Back Better Social Spending Bill Paused
 
The Senate returned to Washington this week from the holiday recess, but no real progress has been made on the advancement of their $1.75 trillion social investment bill, the Build Back Better Act (BBB). On Tuesday, Senate Democratic Whip Dick Durbin (IL) said that negotiations on BBB will pause until the Senate addresses voting rights legislation, which could last through the end of the month. Additionally, Senator Joe Manchin (D-WV) told reporters that negotiations on the bill have come to a halt. Talks are expected to resume, but the timeline is currently unknown.
 
CMS Issues Medicare Advantage and Part D Proposed Rule
 
On Thursday, CMS issued a proposed rule that aims to lower out of pocket Medicare Part D prescription drug costs. The proposed rule would require Medicare Part D plans to pass on savings to consumers at the pharmacy counter, revise Medicare Advantage marketing and communications requirements by strengthening oversight of third-party marketing organizations and seeks greater transparency in Medical Loss Ratio (MLR) reporting by reinstating reporting requirements that were in place from 2014-2017. The proposal also revises dual eligible special needs plan (D-SNP) regulations and proposes that all D-SNPs “establish and maintain one or more enrollee advisory committees.” The press release can be found here and the fact sheet can be accessed here.  
 
CMS to Uphold Vaccine Mandate for Employees at Health Facilities that Receive Funding from Medicare and/or Medicaid Amid SCOTUS Battle
 
CMS announced on December 28 that it would move ahead with enforcement of its vaccine mandate, which requires that workers at health care facilities participating in Medicare and/or Medicaid be fully vaccinated against COVID-19. Workers at these facilities must receive their first shot by January 27 and their second shot by February 28. The mandate will not yet be enforced in the 25 states that have pending lawsuits over the rule. These 25 states include Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia, and Wyoming. The U.S. Supreme Court held a special hearing on Friday, January 7 to consider challenges to the mandate. The Supreme Court also heard arguments over the Occupational Safety and Health Administration’s (OSHA) testing and vaccine mandate, which requires that companies with 100 or more employees require their personnel to either get fully vaccinated against COVID-19 or submit to weekly testing. The full guidance released by CMS can be found here.
 
Protections from Surprise Medical Billing Under the “No Surprises Act” Go into Effect
 
On January 1, surprise medical billing measures went into effect to help protect consumers from high, unexpected medical bills. As a reminder, in late September 2021, the Biden Administration released an interim final rule to further implement the No Surprises Act on surprise medical billing. The new regulations create a process by which providers, health plans, and issuers can settle payment rate disputes. Specifically, under the new regulations, unresolved disputes between providers and insurers are solved by third-party arbiters who will determine a payment rate based on the median in-network rate. Additionally, patients can no longer be charged an out-of-network rate for emergency care received at an out-of-network facility, nor for services received by an out-of-network provider at an in-network facility. House Ways and Means Committee leaders, Richard Neal (D-MA) and Kevin Brady (R-TX), have expressed concerns over the implementation of the No Surprises Act by the Administration, but Congressman Frank Pallone (D-NJ), Chairman of the House Energy and Commerce Committee, and Senator Patty Murray (D-WA), Chair of the Senate Health, Education, Labor, and Pensions Committee, have applauded the new measures. More information can be found here.
 
More than 50 House Democrats Sign Off on Letter Requesting End to Direct Contracting Model
 
On Wednesday, a group of House Democrats, led by Representative Pramila Jayapal (D-WA), sent a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure, requesting that the Direct Contracting Model be permanently ended. The lawmakers also requested that the agencies coordinate the transition of traditional Medicare beneficiaries currently enrolled in these programs back into the traditional Medicare model by July 1 of this year. The full letter can be viewed here.
 
CDC Amends COVID-19 Booster Timeline for Pfizer Recipients and Recommends Booster Doses for Immunocompromised Children Ages 5-11
 
On Tuesday, the CDC announced that it has shortened the booster interval from 6 months to 5 months for people that received two doses of Pfizer’s COVID-19 vaccine. The booster interval recommendation has not changed for the Johnson & Johnson vaccine (2 months) or for the Moderna vaccine (6 months). The CDC also recommended that “moderately or severely” immunocompromised 5–11-year-olds receive an additional dose of the Pfizer vaccine 28 days after their second shot. Pfizer is currently the only COVID-19 vaccine authorized for use in children ages 5-11.
 
Senate HELP Committee to Vote on FDA Commissioner Nominee, Robert Califf, Next Week
 
Next Wednesday, the Senate Health, Education, Labor, & Pensions Committee will vote on whether to send Robert Califf’s FDA Commissioner nomination to the Senate floor for a vote. Senators Joe Manchin (D-WV) and Bernie Sanders (I-VT) have come out in opposition against Califf’s nomination due to his ties to the pharmaceutical industry, but it is expected that he will still garner enough votes to proceed forward. Califf, a cardiologist, previously served as the FDA Commissioner during former President Obama's second administration. Last month, the Senate HELP Committee held a hearing to consider his nomination, and he received bipartisan support.
 
South Dakota to Place Medicaid Expansion on November Ballot
 
Come November, South Dakota will officially let voters decide the fate of Medicaid expansion in the state, by placing the initiative on the ballot. South Dakota is one of only 12 states that have yet to expand their Medicaid programs. If the measure is approved, approximately 42,000 South Dakotans will be eligible to receive Medicaid benefits. 
SENATE HEARINGS AND EXECUTIVE SESSIONS
Senate Health, Education, Labor and Pensions Committee - Hearing
Full Committee Hearing: "Addressing New Variants: A Federal Perspective on the COVID-19 Response."
01/11/2022, 10:00 AM EST
HOUSE HEARINGS AND EXECUTIVE SESSIONS
N/A
ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
 
Food and Drug Administration
 
Guidance Documents from the Centers for Disease Control and Prevention

National Institutes of Health
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